Quality Systems Program Director (QMS), Plymouth, MN at COV Covidien LP

# A Day in the Life

The Quality Program Director will lead the Quality Management System (QMS) and overall quality strategy for the PVH Operating Unit (OU), while also providing strategic quality leadership for acquisitions and divestitures. This role will oversee QMS activities through a dotted-line team structure and be responsible for preparing the organization for FDA QMSR inspections, including leading FDA front-room inspection activities.

The PVH OU includes a design center and manufacturing sites located in Minneapolis, Galway, Tijuana, and Danvers, with cross-functional collaboration extending to Irvine. In addition, the Director will drive the quality strategy for the PCH OU by establishing top-down quality KPIs and aligning bottom-up operational strategies and OKRs to support business objectives.

The Director will also play a key role in mergers and acquisitions by participating in quality due diligence for potential acquisitions, assessing quality systems and compliance risks, and supporting integration planning, cost modeling, and post-acquisition quality integration efforts. This is an onsite position based in Plymouth, MN.

Primary Responsibilities:

• Support quality due diligence, integration planning, and execution activities for acquisitions and business integrations.
• Develop and lead the overall quality strategy and organizational Objectives and Key Results (OKRs), aligning enterprise, operating unit, and functional priorities.
• Serve as the Quality Management System (QMS) leader, establishing and executing strategies to ensure FDA inspection readiness, including compliance with Quality Management System Regulation (QMSR) requirements.
• Act as the front-room leader during FDA inspections and support other regulatory inspections at the Minneapolis site as needed.
• Partner with and provide guidance to the PVH manufacturing facility on Quality Management System initiatives, regulatory compliance, and quality best practices.
• Collaborate closely with the existing QMS support team responsible for Quality Management Review (QMR), Key Performance Indicators (KPIs), Corrective and Preventive Actions (CAPA), and other quality system processes.
• Drive continuous improvement initiatives to strengthen quality systems, regulatory compliance, and operational effectiveness.
• Build strong relationships with cross-functional stakeholders to ensure consistent implementation of quality standards and regulatory expectations.

Must Have: Minimum Requirements- To be considered for this role, please ensure the minimum requirements are evident in your applicant profile:

• Baccalaureate with minimum of 10+ years of experience with 7 years of managerial experience OR advanced degree with a minimum of 8 years prior relevant experience, with 7 years of managerial experience.

Nice to Have:

• FDA experience: A demonstrated ability to interacted with FDA during audits/ questions
• Quality Management System Regulation (QMSR) experience is preferred.
• Leadership: A demonstrated ability to collaborate with mfg sites to reduce the overall compliance gaps
• Excellent interpersonal and communication skills.
• Excellent project and program management skills.
• Quality orientation and patient focus.

About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America). A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

LTI Eligible: This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.

Physical Job Requirements

U.S. Work Authorization & Sponsorship

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# Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$184,000.00 - $276,000.00

This position is eligible for an annual long-term incentive plan.

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